MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. (CS) SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 27MJ-501

Device Problems Fracture (1260); Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/16/2014

Event Type  Injury  

Event Description

Four months following implant, the patient reported feeling unwell.Imaging revealed a leaflet was ¿stuck¿ preventing the valve from opening properly.As the valve was explanted, one of the leaflets dislodged and fractured.The entire valve was retrieved from the patient and another 27mm masters series mhv was implanted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of this investigation concluded one leaflet was fractured, orifice damage was noted, and pannus formation with abundant gram positive cocci was identified on both the inflow and outflow orifice surfaces and sewing cuff.Special stains were positive for organisms, and no significant acute inflammation was present.The evenness of the coating and unremarkable nature of the material, ruled out any suggestion material defect.The fractured leaflet and orifice damage were caused by an external force applied to the leaflet and orifice, which overstressed the carbon material.There was no evidence found to suggest the cause of the orifice damage, leaflet fracture, and pannus formation was due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the orifice damage, leaflet fracture, and pannus formation remains unknown.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4209212
• MDR Text Key: 5038895
• Report Number: 2648612-2014-00046
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PP810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/11/2018
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: 4385819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR